FDA Addresses the Challenges of eSource Utilization

Heather Paden, MS, Head, Clinical Operations, PROMETRIKA, LLC

PROMETRIKA Clinical Operations was recently faced with the challenge of initiating the first clinical trial for a specialized research group at a large, academic, world-renowned, oncology research hospital in the US. The excitement of beginning this phase of product development came with many practical challenges – one of which was how to collate and standardize clinical data collected by many non-integrated electronic health record (EHR) systems.

Until the recent wide-spread adoption of EHR systems, source documentation – all procedures, results and medical assessments recorded for a patient – was provided on paper in physical patient charts. Today, most of this information is recorded directly into databases by healthcare personnel. In response, the biopharmaceutical industry envisions the use of EHRs to improve the efficiency and accuracy of data collection in clinical trials. However, the greatest obstacle to integration of EHRs with the electronic data capture (EDC) systems used in the industry is the lack of standardization among EHR products.

Earlier this month (July 2018), FDA issued a guidance entitled “Use of Electronic Health Record Data in Clinical Investigations”. The aim of the guidance is to help biopharmaceutical sponsors determine whether and how to use EHR data in clinical trials. The recommendations hinge on the interoperability of EHR and EDC systems and on the best practices for using EHR data.

Interoperability refers to the ability of products, technologies, or systems to exchange information and to use that information without special user efforts. An interoperable system can electronically transmit data from an EHR to an EDC system. Current challenges to this function include the differing, complex, and diverse clinical data standards among the healthcare and clinical research communities. Efforts are currently underway to create open standards and standards stipulated by the Office of the National Coordinator (ONC) for Health Information Technology’s (Health IT) Interoperability Standards Advisory.

The ONC, not the FDA, is the agency responsible for overseeing EHRs and other health IT that provide electronic data. Thus, FDA cannot assess compliance of EHR systems with 21 CFR part 11. However, FDA’s purview is the quality and integrity of the data from EHRs used in clinical trials. Thus, FDA will review a sponsor’s EDC system that extracts EHR data for compliance with part 11. Data validation is another sponsor challenge. The sponsor must have procedures in place to continually ensure the integrity and security of EHR data transmitted to the EDC.

In the new guidance, the FDA has provided the industry with suggested best practices for using EHR data in clinical trials. The ONC offers a voluntary certification program for health IT. FDA encourages sponsors to use sites with certified EHR systems and to document manufacturer, model number, and version number of each EHR system used in a trial. Maintenance of certification for at least the duration of the trial should be monitored by the sponsor. FDA also recognizes that foreign EHR systems are not subject to ONC requirements or certification; yet, data from foreign systems are integral to submissions made to FDA. The guidance gives sponsors factors to consider when evaluating foreign EHR systems prior to including a foreign site in a trial intended for FDA submission.

Nearly every hospital or doctor’s office has a different EHR system, configured and customized for that site. In a large institution, individual departments and laboratories, ostensibly under the same research umbrella, have unique systems that do not cross-reference and substantiate each other. Additionally, today’s technological developments are driving rapidly changing methods of data acquisition and analysis. Wearable devices and patches, cell phones, e-pads, and “smart” pill bottles transmit data directly to EHRs and EDCs. As exciting as all of these advances are, the need for data quality, integrity, and security remains. The FDA’s recent guidance will help the industry determine the best procedures to ensure that these goals are met. PROMETRIKA’s recent real-world experience clarified the need for timely industry action on the interoperability of EHR and EDC systems.